Earlier this month, Senator Thom Tillis (R-NC) sent a letter to the U.S. Patent and Trademark Office (USPTO) and to the U.S. Food and Drug Administration (FDA), expressing concern about policymaking on drug patents and drug prices being driven by a narrative rooted more in policy goals than in actual data. He sent another letter to a policy organization, Initiative for Medicines, Access, and Knowledge (I-MAK), which has held itself out as go-to source for data on the number of patents covering drugs. I-MAK has become very popular; its drug patent numbers are invoked as fact by congresspersons, academics, congressional witnesses, and policy activists. Senator Tillis is to be commended for expressing serious concerns about the unreliability of drug patent numbers repeatedly invoked in the policy debates over drug prices in Washington, D.C. His letter to the USPTO and FDA requests that the agencies engage in an “independent assessment and analysis of the sources and data that are being relied upon by those advocating for patent-based solutions to drug pricing.”

Invoking familiar warnings about grave threats to U.S. innovation, 23 chief legal officers of big companies spanning industries from high-tech, internet and streaming to auto, financial services and home security, recently sent a letter to Secretary of Commerce Gina Raimondo calling on her to “immediately repeal the NHK-Fintiv rule” established by former U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu via precedential Patent Trial and Appeal Board (PTAB) decisions. According to the letter, NHK-Fintiv practice has written vital protections intended by the America Invents Act out of the law without public notice or comment, and “has caused—and continues to cause—immediate and irreparable harm to American innovators and manufacturers.”

An anti-suit injunction is an interim order issued by a court in one jurisdiction that prohibits a litigant from initiating or continuing parallel litigation in another jurisdiction. The practice of the anti-suit injunction is traced back to fifteenth century England, where royal courts issued writs of prohibition to stay parallel proceedings in the ecclesiastical courts or common law courts. Initially, the use of anti-suit injunctions was limited in England. By the nineteenth century, however, their use expanded to prevent litigation in other British colonies and eventually foreign countries.

A curiosity of the intellectual property field is the lack of emphasis on commercialization. While there are numerous resources that describe how to patent an invention, there are hardly any that offer processes and frameworks for transforming ideas into products and services. This is a disservice to creative people, because they are motivated to share their creativity with the world — not merely protect what they invent. In a new episode of the podcast “Understanding IP Matters,” the fascinating serial entrepreneur Tiffany Norwood laments that while “so much of our world is driven by imagination, only a few of us take our imagination seriously.

You might think the last thing the President needs as his poll numbers are plunging is pressure to make an unforced blunder crippling U.S. innovation. Under the pretext of expanding U.S. manufacturing capability, some are pushing a provision to a pending Executive Order on manufacturing allowing the bureaucracy to micromanage our technology transfer system. That’s already happened at the Department of Energy (DOE), and the disastrous consequences are just becoming apparent. This is being sold as a way of increasing domestic manufacturing capacity, which is rightly a priority of President Biden. But extending a flawed idea across all R&D agencies undermines the public/private R&D partnerships which restored our technological leadership—without doing a thing to broaden our manufacturing base.

The CAFC on Friday, February 11, denied a petition for writ of mandamus filed by B.E. Technology in November of last year asking the court to intervene to “prevent an unconstitutional deprivation of B.E.’s property rights in the onslaught of IPR proceedings that have been brought to challenge the validity of its most critical patents.” B.E. has been embroiled in litigation with big tech companies like Facebook, Twitter and Google for close to a decade now. The CAFC said in its denial that “B.E. has not shown a clear right to a different result here by relying primarily on a self-published article that is outside of the record.”

This week in Washington IP news, the Senate Banking Committee will hold a hearing to discuss last November’s report on stablecoins by the President’s Working Group on Financial Markets. Over in the House of Representatives, the Communications Subcommittee will conduct an oversight hearing of the National Telecommunications and Information Administration (NTIA), while the Energy Subcommittee debates a proposed bill that would create a series of climate research centers across the United States. Elsewhere, the Patent Trial and Appeal Board’s (PTAB’s) Diversity, Equity, and Inclusion Committee discusses its efforts to increase accessibility at the PTAB, while New America hosts an event to discuss the possibility that nuclear energy could be better adopted into national energy systems in order to meet climate goals.

Earlier this month, IP management and analytics firm Anaqua issued statistics on patents granted by the U.S. Patent and Trademark Office (USPTO) during 2021, providing a snapshot of the companies and countries earning the greatest number of U.S. patents, as well as the technological areas where most innovations are being protected. Among the report’s greatest takeaways include the relatively strong state of innovation through the COVID-19 pandemic. Anaqua’s report also reinforces the notion that China is slowly but surely becoming a major player in the U.S. patent system.

North Carolina Republican Senator Thom Tillis has raised the possibility of a combined patent, trademark and copyright office so as to improve the federal government’s approach to all aspects of intellectual property. On January 26, the Senator sent a letter to the Chairman and Counsel for the Administrative Conference of the United States (ACUS) to undertake a study into whether there should be a unified, independent Intellectual Property Office. The Administrative Conference is an independent agency that makes procedural recommendations to the federal government. Tillis’ request is premised upon his view that currently there is a fractured approach to intellectual property in our federal government, with multiple IP functions spread across different agencies, leading to conflicting policy agendas and unnecessary bureaucracy. Tillis is the Ranking Member of the Senate’s Judiciary Committee’s subcommittee on Intellectual Property.

On February 10, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the U.S. District Court for the District of New Jersey, explaining that the district court did not err in finding several Adapt Pharma patents obvious. The asserted claims relate to U.S. Patent Nos. 9,468,747; 9,561,177; 9,629,965; and 9,775,838 (collectively, the “patents-in-suit”). The patents-in-suit claim methods of treating opioid overdose by intranasal administration of a naloxone formulation, as well as devices for intranasal administration. Naloxone is the active ingredient in Adapt’s NARCANâ Nasal Spray and is an opioid receptor antagonist, thus helping reverse the effects of opioid overdose. The opinion was authored by Judge Kara Stoll; Judge Pauline Newman dissented.

Preparing an Information Disclosure Statement (IDS) can be stressful. The United States Patent and Trademark Office (USPTO) has very strict guidelines which must be followed precisely to avoid errors. Failure to adhere to these guidelines will result in additional costs and time spent in filing the Information Disclosure Statement (IDS). Often, errors are made due to changes in requirements made by the USPTO, failing to adhere to deadlines, and lack of providing adequate reference materials. While these mistakes can happen frequently, there are steps patent filers and intellectual property (IP) professionals can take to avoid errors. Below are some of the most common IDS-related mistakes made by patent filers and practitioners.

This week in Other Barks & Bites: the The Federal Circuit denies rehearing in Teva’s case with GlaxoSmithKline’s regarding Teva’s induced infringement of a GSK patent directed to a method of treating Congestive Heart Failure; the Eleventh Circuit affirms that press release statements regarding patent licensing and other business activities by Revolutionary Concepts included false statements violating federal securities law; the World Intellectual Property Organization reports that nearly 55% of international patent application filings during 2021 were submitted by Asian entities; Judge Newman authors a dissent arguing flaws in a Federal Circuit panel majority’s decision to affirm the invalidity of patents covering the opioid overdose treatment NARCAN; Disney’s quarterly earnings show strong results in both streaming subscribers as well as theme park attendance; White House OSTP Director Eric Lander resigns following an investigation into bullying allegations; and a federal indictment surrounding the theft of walkie talkie trade secrets from Motorola Solutions was unsealed in Northern Illinois federal district court.

Last week included the end of January, which meant district court filings spiked as they usually do at the end of the month, with 92 new patent filings, and plenty of terminations (66). Patent Trial and Appeal Board (PTAB) challenges (41) were propped up by filings between Ericsson and Apple in their large-scale 5G dispute, Samsung challenging an entire portfolio, it seems, on some assets owned by a subsidiary of the perennial file-and-settle consort IP Edge (which seems to be getting big eyes and going after bigger players these days, after years of filing thousands of suits against smaller companies); a number of competitor-competitor chipmaker suits, including one by Infineon against more Vector Capital-backed Monterey Research semiconductor patents; challenges by Nokia against monetizer IP Bridge patents; and a number of petitions filed by Chanel against Molo Design Ltd.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed the U.S. District Court for the District of Pennsylvania’s summary judgment that a medical device design patent was not invalid under the on-sale bar. Junker v. Medical Components, Inc. The district court found the patent was infringed and awarded damages in the amount of $1,247,910. But the CAFC held that a letter sent by the inventor’s business partner to Boston Scientific Corporation in 1999 represented a commercial offer for sale of the claimed design.

Judge Leonard Philip Stark was confirmed by the U.S. Senate yesterday to be the next judge on the U.S. Court of Appeals for the Federal Circuit, replacing Judge Kathleen O’Malley. O’Malley announced in July of last year that she will officially retire on March 11, 2022. Stark was confirmed by a vote of 61-35, which is reportedly one of the most bipartisan votes so far during President Joe Biden’s administration.